This is Steven Salzberg's blog on genomics, pseudoscience, medical breakthroughs, higher education, and other topics, including skepticism about unscientific medical practices. Here's where I can say what I really think about abuses and distortions of science, wherever I see them.

Taking advantage of cancer patients

How much is 10 months of your life worth? What if you only have 14 months to live?

How should we react to a doctor who takes advantage of some of the most desperate cancer patients to sell them a therapy that doesn’t work? What if, after scientific evidence shows it isn’t working, he continues to promote his therapy and offer it to patients? What if he chooses one of the most intractable cancers, pancreatic cancer, which is a near-certain death sentence, and tells patients to use his therapy instead of the one therapy that offers a small chance of working?Is scorn a strong enough feeling for such a doctor? Shouldn’t we try to do everything we can to stop him? Well, please meet Nicholas Gonzalez, M.D., who, according to his very own website, treats pancreatic cancer with “diet, supplements (with proteolytic enzymes for cancer patients) and detoxification routines such as coffee enemas.”

Gonzalez invented the “Gonzalez regimen” nearly 30 years ago, and he claims on his website that pancreatic cancer patients in his care have experienced near-miraculous recoveries and far longer survival times than patients receiving normal care. After lobbying Congress directly (again, according to his own website), Gonzalez convinced NIH (with help from Rep. Dan Burton of Indiana) to fund a trial of his regimen, comparing it to the only available chemotherapy. The regimen is quite complicated, so I’ll reproduce it exactly here, from the NIH trials website:

”Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.”

Not an easy therapy for the patients, who had to consume over 100 pills a day in addition to the strict diet, enemas twice a day, and special baths. But does it work?

NO. In fact, the results of this trial were finally published just last month, in the Journal of Clinical Oncology – after 4 years delay – and we now learn that patients undergoing the Gonzalez regimen died in just 4 months, on average, compared to 14 months for patients in chemotherapy. Now 14 months might not seem like a good result, but when you only have 14 months to live, I’m sure you don’t want to die 10 months earlier while taking hundreds of pills and enduring twice-daily coffee enemas. This is quackery of the worst kind, killing the patients and making them miserable for the few months they have to live – according to the JCO article, patients had a worse quality of life under the Gonzalez regimen as well as having a much shorter survival time.

(Note that Kimball Atwood written extensively on the problems with the Gonzalez regimen, including links to his earlier posts on this subject, so I’ll try not to repeat too much of his excellent summary here.)

Not surprisingly, Gonzalez has had a major falling out with his collaborators on the study, who published the article without him as a co-author. So how did he react to these results? Did he have second thoughts, and perhaps consider whether he should stop selling his ineffective therapy (and offering false hopes) to pancreatic cancer patients?

Unfortunately, Gonzalez hasn’t changed his beliefs one bit, and he posted a lengthy “rebuttal” of the JCO article on his site soon after he learned about the article (which he apparently was unaware of until it appeared). In it, he boasts about how he alone was responsible for getting the study funded (“the grant was approved and awarded during a face-to-face meeting between me and the then NCI Director, Dr. Richard Klausner, held in the office of Congressman Dan Burton”), complains about being betrayed by the authors (his former collaborators), and maintains that it “implies falsely the study proves chemotherapy more effective than my treatment.” He goes on endlessly, complaining about how the scientists who ran the study at Columbia University mismanaged everything, and claiming that this is why the results didn’t show that his regimen worked. According to his diatribe, NIH, NCI, and the Columbia scientists were all part of a big conspiracy to hide the truth about his regimen. If there's any conspiracy here, it's Gonzalez's efforts to delay publication of this study and hide the results from his potential future patients (or should I say victims?). (And for those who want to blame "big pharma" for conspiring against Gonzalez, note that he proudly reports on his site that he has received millions of dollars in funding from two large for-profit corporations.)

The story of how this study got started in the first place is disturbing on many levels, and I will point readers again to a blogpost by Kimball Atwood’s for more details. Among other things, the investigators at Columbia University were warned repeatedly about violating IRB protocols on informed consent. And the basis for the study was a claim by Gonzalez – based on 11 patients whom he claims to have treated for pancreatic cancer – that he was achieving survival times substantially longer than standard therapy. It appears that he (in the most generous interpretation) chose selectively among patients to produce this claim.

Gonzalez has been investigated and put on probation in the past by the N.Y. medical licensing authorities, and has been sued successfully for malpractice, after recommending that a woman forego standard cancer therapy and take his treatment instead. (As Quackwatch documents, “he claimed that the cancer was cured even though it was progressing. It eventually damaged her spine and left her blind.”) Despite these past mishaps, he continues to offer his regimen to cancer patients, and his website today still contains claims of multi-year survival for many of his past patients.

Gonzalez is taking advantage of vulnerable, desperate patients and selling them a painful treatment that merely kills them faster. NIH deserves blame here too, as does NCCAM (the National Center for Complementary and Alternative Medicine), which funded this unethical trial, and especially Congressman Dan Burton, whose support for pseudoscience has in this case caused inexcusable harm to patients whose lives were cut short. And the physicians at Columbia who went ahead with the trial are not without blame either.

How should I react to Gonzalez? Should we give him the benefit of the doubt, and assume he’s just trying to do the best for his patients? Should we believe his claims of a conspiracy and fund more investigations into his elaborate regimen for treating pancreatic cancer? Or should we take away his license, and do anything else we can to prevent him from offering this therapy ever again? I know what I think. I am appalled.

22 comments:

Steven:Compare your post on the effectiveness of flu vaccination and your view of the pancreatic cancer paper. Do you feel that you are willing to explain away negative data on flu vaccine effectiveness and yet with the cancer paper perhaps you feel that is the final word?

Is it also fair to say that, with exceptions (eg Hodgkin's disease), cytotoxic chemotherapy is of questionable value and most times of zero curative value?

Also, is it fair to say that cytotoxic chemotherapy many times helps kill the patient or gives them horrendous side effects (eg vomiting, diarrhea, immune system damage, organ damage)?

Talk about comparing apples and oranges - you are making several common logical fallacies. First, you create a false dichotomy: chemotherapy is "of questionable value and most times of zero curative value" - false. Chemotherapy encompasses a very wide range of drugs and cancers, each one different, and its effectiveness varies across a broad spectrum, ranging from highly effective, even curative for some cancers, to minimally effective. Second, you employ a non sequitur - data on flu vaccine effectiveness is simply irrelevant to the effectiveness of the Gonzalez regimen. I'm not going to try to compare the two because they are not comparable.

I think you may have created a straw man. I specifically mentioned cytotoxic chemotherapy ("CC"). I'm not referring to any therapy involving a chemical.

There are cancers that can be cured through CC, as I indicated; unfortunately, I believe the great majority cannot.

How do you define minimally effective? Ask an oncologist if he would ever subject himself to a "minimally effective" CC. Ever.

(Imagine the constellation of side effects of a minimally effective CC.)

If an alternative cancer therapy were minimally effective, would you be so charitable?

With respect to non-sequitur, I do note that you may have two standards.

Is it correct to say that if a vaccine has multiple studies that show ineffectiveness in older people, you are willing to entertain a guess as to why the vaccine is actually effective?

And yet if a single study (that is not free of controversy, see Gonzalez's comment) of an alternative cancer treatment is published and it claims the treatment is ineffective, do you feel that is the final word?

If you feel strongly that way, how did you feel about the initial data on Vioxx? Or Fen-phen?

For so many years we followed the treatment paradigm of CC with, I think, many times, lousy results (ie no cure). Sure the pharmaceutical industry made money; I suppose that's one way to measure success. But did we help people most of the time?

If the gov't funds a study of an alternative cancer therapy and it's done ethically, I think that can be a good thing.

If a person wants to work on more studies of CC, or ghost write articles for academicians, or create a fake medical journal, then that person should work for the pharmaceutical industry. Perhaps we have an idea of the ethics in pharmaceutical industry.

Let me close by saying, I appreciate being given a chance to respond to your posting. I may disagree with you on certain things, but I think that by listening to the other side of an issue things can be learned.

I agree that you are too quick to condemn Dr. Gonzalez. My daughter is a researcher and is all too aware of the many weaknesses in the current research system. One negative study is not "proof" of anything.

My husband fought stage III pancreatic cancer for 27 months with a combination of alternative and conventional treatments. He started with radiation and chemotherapy for five weeks, which which made him sick and weak, but slowed down the disease. He then did nutritional/alternative treatments for six months, which built up his immune system and enabled him to have many good days. However, the disease still progressed, but much slower than it would have without the alternative treatments. When his pain returned, he again went the conventional route of chemotherapy. Again, he was weakened and sickened, but the disease was kicked back one more time. This time, when he felt good he chose to travel, rather than do more treatments, and we had several good months together. When the pain returned, we contacted Dr. Gonzalez' office, and was politely told that they could do nothing for my husband. If Dr. Gonzalez was as unethical as you infer, he would have taken advantage of us.... but, he didn't. That says something in his favor.

When my husband's pain returned again at the beginning of last year, trying more chemotherapy did not help, nor did more nutritional/alternative treatments. He died last June. Pancreatic cancer is a hideous disease, and all possible avenues of attacking MUST be explored.

Some of you are far too tolerant of Gonzalez. Sure, one negative study isn't a convincing proof that his method is a failure - but what about the nearly 30 years of his inflicting an unproven treatment on desperate patients? He had plenty of time to gather data proving his method worked, but he never did, for the simple reason that the method doesn't work. (And testimonials may sound compelling, but they aren't evidence. Many cancer patients try "alternative" treatments and report, subjectively, that the treatments worked, but those reports are usually just mistaking correlation with causation - that is, the patient improves a little bit, perhaps due to the normal course of the illness, perhaps due to other causes - and the patient naturally gives credit to the "alternative" therapy.)

And yes, Gonzalez's credentials look solid, but unfortunately good credentials don't guarantee good science. In his case we can look at his behavior, which I think says it all.

Thank you for this blog post Steven. I too am appalled about Dr. Gonzales using vulnerable cancer patients for his own profit. You would think that in 30 year of practice Dr. Gonzales would have gathered more than anecdotal evidence to support his method. I know desperate cancer patients would try anything out of hope, but maybe given these negative results they will think twice before choosing such a painful protocol as the one proposed by Dr. Gonzales.

It's remains unclear to me what you're standards are for evaluating effectiveness of a treatment, be it vaccine or cancer treatment.

I assume you have spoken to none of Ganzalez's previous patients or family members of previous patients.

Could it be that that some of us are not too tolerant of Gonzalez but rather you are too intolerant of anyone going off the reservation (in other words, thinking that there could be an alternative better than chemotherapy)?

Maybe Gonzalez is incorrect but remember pancreatic cancer is a horrible disease that traditional medicine (after decades of having chemo as a treatment for cancer) usually cannot cure.

Anon: I would laugh, but this isn't funny. Gonzalez's "ideas" are 30 years old and they have never worked. Hardly new.

Readers: I suspect that some people posting as "Anonymous" here might have direct connections with Gonzalez, or other reasons to defend him. There seems to be a theme in some of these remarks that "all possible avenues must be explored" as if that were justification for treating patients with ineffective snake oil. This is a classic defense of quacks, who often claim that their "new" ideas are just too radical for mainstream medicine.

New ideas are great, and badly needed for pancreatic cancer. But all ideas must prove themselves through rigorous scientific testing. Quacks don't get a free pass.

RJ: that study is the 11-patient study I mentioned in my post. Kimball Atwood (see the link in my posting) and also Orac pointed out that this study has serious methodological problems, such as that Gonzalez cherry-picked 11 patients over a 3-year period. This result - questionable though it was - was the basis for Gonzalez's lobbying efforts to get NIH to fund the larger trial that was the main topic of my posting.

I agree that alternative medicine rarely has any effect beyond placebo. However that doesn't at all mean that alternative medicine has no right to exist. Many people don't consider alternative medicine anyway because they know it doesn't work; others try it and get the placebo effect, which sometimes all one can get from any type of treatment.

The only real problem happens when there is a very effective traditional treatment and it's ignored in favor of an alternative one, for example if instead of surgically removing an appendix one treats it with acupuncture. This extreme rarely happens as most people are smart enough not to do that and most practitioners are smart enough not to expose themselves to such lawsuits.

When it comes to something as untreatable as pancreatic cancer, the choice of treatment (or no treatment at all) becomes a matter of preference. By attacking alternative medicine you are trying to limit people's choices, decide what's good for them. Yes, the choice has to be informed, and that's why funding and research and publications are needed, but if somebody chooses to believe something irrational, that's often purely their choice and not inability to see the facts. Since a large number of people make the choice towards alternative medicine, and these people pay taxes, it's only fair to allocate some of this money to study and develop alternative medicine.

I don’t think Dr. Salzberg is claiming that chemo is painless and 100% effective as one of the posters seems to imply. Chemo certainly is painful, uncomfortable, expensive, etc. It is also the most effective treatment currently available for most types of cancers. Dr. Gonzalez’s regiment is painful and ineffective. It therefore takes advantage of a person’s desperation in a particularly cruel way.

Furthermore, I want to add that I don’t think personal anecdotes add anything positive to scientific discussion. The only way of finding out the effectiveness of a treatment is not whether a person claims it did wonder for their uncle Herman, but by doing controlled studies. And if those studies show that a treatment is ineffective, then it doesn’t matter what your uncle Herman says b/c it didn’t work. Something else may have happened – there is individual variability, which is why studies are done randomly and in significant numbers—but it wasn’t the coffee enema.

Finally, the personal narratives are pointless in terms of the debate because they often tend to set up one person as the ‘victim’ and the other persons as insensitive to the suffering of the victim – as if that had anything to do with the original discussion. In a sense one comes off as ‘attacking the victim’. If I am having a debate with someone whose spouse died of cancer after painful treatment, there really is nothing I can say, once their partner’s death has been brought up, that won’t come off as callous. I may be completely right –and for the sake of this point let’s say I am—but it will still come off badly. The debate is now pointless since it’s no longer a discussion about treatment but whether the defense of this treatment is an insult to this person and a denial of their suffering.

Or it could be that Gonzalez distorted and/or faked evidence in his original study, as has already been argued by other scientists. If you see enough pancreatic cancer patients, some will survive 3 years - so you can simply choose to report results on them and ignore the others. The new study shows that patients undergoing Gonzalez's protocol die 10 months SOONER than patients undergoing standard chemotherapy. So yes, it could be that the treatment has some effect: it might be that it kills patients faster.

Dr Gonzalez methods remind me a lot of Dr Milan Brych who setup cancer clinics in New Zealand, Cthe Cook Islands, Australia, and Los Angeles in the 1970's and 1980's. This page is a little biased but there are others that still support his work.